Comparison of ultrasound guided injection of local anesthetic between back muscle planes to direct injection in and around the back muscles, for post operative pain relief after spine surgeries.

COMPARISON OF BILATERAL ERECTOR SPINAE PLANE [ESP] BLOCK WITH LOCAL WOUND INFILTRATION OF ANESTHESIA [LWIA] FOR POST OPERATIVE ANALGESIC EFFICACY AFTER OPEN LUMBAR FUSION SURGERY- A PROSPECTIVE RANDOMISED TRIAL - ESWILF

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/06/034407

Enrollment

Registered

2021-06-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Erector spinae plane (ESP) block: Ultrasound guided erector spinae plane (ESP) block using 15 ml of 0.375% ropivacaine on each side prior to surgery (total dose of ropivacaine 112.5 mg)

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18-75 years old, with American Society of Anaesthesiologists Physical status 1-3 scheduled for open lumbar fusion surgery.

Exclusion criteria

Exclusion criteria: 1. Allergy or intolerance to any of the drugs used in the study. 2. Kidney, liver, central or peripheral neurologic disease, coagulopathy. 3. Pre-existing neurologic or anatomic deficits in the lower extremities. 4. Severe psychiatric illness. 5. Infection in the intervention region. 6. History of narcotic drug use within 24 hours before operation. 7. History of chronic pain, narcotic substance or alcoholic dependence.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to compare 24 hour post-operative cumulative analgesic consumption between erector spinae plane (ESP) block with local wound infiltration of anaesthesia (LWIA) after open lumbar spine fusion surgeries.Timepoint: 24 hours post surgery	—

Secondary

Measure	Time frame
1. Comparison of static pain, scores between the 2 groups, as assessed by the verbal numeric rating scale (VNRS) at 0, 1, 6, 12 and 24 hours 2. Comparison of dynamic pain score between the 2 groups, as assessed by the verbal numeric rating scale (VNRS) at12 and 24 hours. 3. Comparison of quality of recovery (QOR-40) score between the 2 groups at postoperative day 2. 4. Postoperative nausea and vomiting will be noted and graded according to a standard PONV scoring system.Timepoint: At 0, 1, 6, 12, 24 hours for static pain and at 12 and 24 hours for dynamic pain. QOR-40 on day two.	—

Measure

Time frame

1. Comparison of static pain, scores between the 2 groups, as assessed by the verbal numeric rating scale (VNRS) at 0, 1, 6, 12 and 24 hours 2. Comparison of dynamic pain score between the 2 groups, as assessed by the verbal numeric rating scale (VNRS) at12 and 24 hours. 3. Comparison of quality of recovery (QOR-40) score between the 2 groups at postoperative day 2. 4. Postoperative nausea and vomiting will be noted and graded according to a standard PONV scoring system.Timepoint: At 0, 1, 6, 12, 24 hours for static pain and at 12 and 24 hours for dynamic pain. QOR-40 on day two.

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Countries

India

Contacts

Public ContactPankaj yadav

Northern railway central hospital

dr.sushilkrishnan@gmail.com9717630552

Outcome results